Class 2 Device Recall Flat Panel Detector

• Date Initiated by Firm: December 20, 2021
• Create Date: January 12, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0492-2022
• Recall Event ID: 89218
• 510(K)Number: K181670 K181804 K182415 K182546
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• Product: Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C, INFX-8000F, and INFX-8000H.
• Code Information: SID: 30039059, Alphenix System Serial Number: BGC20Y2010, & Flat Panel Detector Serial Number: C1B20Y2215 SID: 30030612, Alphenix System Serial Number: B8D20Z2001, & Flat Panel Detector Serial Number: C1B20Z2218; SID: 30030612, Alphenix System Serial Number: B8D20Z2001, & Flat Panel Detector Serial Number: C1B20Z2219; SID: 30046247, Alphenix System Serial Number: B1B20Z2001, & Flat Panel Detector Serial Number: C1B20Z2221; SID: 30064041, Alphenix System Serial Number: BGD2172011, & Flat Panel Detector Serial Number: C1B2172234; SID: 30065145, Alphenix System Serial Number: B1E2172002, & Flat Panel Detector Serial Number: C1B2172235; SID: 30058149, Alphenix System Serial Number: B1E2152001, & Flat Panel Detector Serial Number: C1B2152230; SID: 30002089, Alphenix System Serial Number: BHC20Z2003, & Flat Panel Detector Serial Number: C1B20Z2217.
• FEI Number: 2020563
• Recalling Firm/ Manufacturer: Canon Medical System, USA, INC.; 2441 Michelle Dr; Tustin CA 92780-7047
• For Additional Information Contact: Ms. Terry Schultz; 800-421-1968
• Manufacturer Reason for Recall: Abnormal images such as horizontal stripes may be displayed and recovery may not not be possible by restarting the system. The worst case scenario is an operator who is working without a workable image may remove a catheter from the patient's blood vessel and damage the blood vessel.
• FDA Determined Cause: Vendor change control
• Action: On 12/21/2021, the firm notified affected customers via a letter titled, "URGENT: MEDICAL DEVICE CORRECTION." The letter indicated, "Corrective Action: When the new parts become available, your Canon service representative will contact you for an appointment to schedule the installation of the modified x-ray flat panel detector and will install on your system. Requests to Customers: Should this problem occur before the modified x-ray flat panel detector is installed on your system, please attempt computer reboot, and contact your Canon service representative. If you have any questions regarding this matter, please contact your Canon service representative. Please share the contents of this letter with all users and reviewing radiologist as well as clinical engineering or biomedical group at your facility. In order to comply with the FDA record keeping requirement, Canon respectfully requests that the attached form be completed and returned. Please fax it to the toll free number at the top of the form, or return via email to RAffairs@us.medical.canon. Thank you for your urgent attention to this matter." If you have any questions regarding this letter please contact the Regulatory Affairs Manager at 800.421.1968 or your Canon service representative at 800.521.1968.
• Quantity in Commerce: 8
• Distribution: US Nationwide distribution in the states of DE, FL, LA, MT, NJ, OH, and WV.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = OWB